Cardiac SurgeryNCT00547859
Relationship Between Microcirculatory Flow Alterations and Tissue Metabolism
An observational study of Cardiac Surgery, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial summary
The purpose of this study is to correlate microcirculatory flow and rectal anaerobe cellular CO2 production in patients after cardiac surgery. The hypothesis is that such a correlation exists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2007to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: post cardiac surgery patients in the first two hours of ICU treatment
Who may be able to join
- cardiac surgery
- informed consent
- age > 18
Who cannot join
- pregnancy
- off pump procedure
- rectal fecal contamination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Microcirculatory Flow and Rectal Anaerobe Cellular CO2 Production in Patients After Cardiac Surgery
The purpose of this study is to correlate microcirculatory flow and rectal anaerobe cellular CO2 production in patients after cardiac surgery. The hypothesis is that such a correlation exists.
Read the detailed description
Sidestream Darkfield imaging is used to determine rectal microcirculatory flow in patients after postoperative cardiac surgery. At the same time PCO2 gap is established by monitoring rectal CO2 (tonometry) and arterial CO2 After initial enrollment and first analysis we also includes a control group with equal inclusion criteria for sublingual SDF imaging.
- Conditions
- Cardiac Surgery
- Keywords
- microcirculation, cardiac surgery, metabolism, capnometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation between MFI (by SDF) and capno
Measured: 6 months
Secondary outcomes (1)
Relevance of changes in flow and metabolism
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionOct 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Investigators
- E.C. Boerma, MD, Principal investigator, Frisius Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547859
- Sponsor's protocol ID
- TPO 503
- Other IDs
- ABR 19609
- Status last verified
- Nov 2008
- First submitted
- 22 Oct 2007
- Last updated
- 26 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Boerma EC, Mathura KR, van der Voort PH, Spronk PE, Ince C. Quantifying bedside-derived imaging of microcirculatory abnormalities in septic patients: a prospective validation study. Crit Care. 2005;9(6):R601-6. doi: 10.1186/cc3809. Epub 2005 Sep 22.
PubMed 16280059
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Microcirculatory Flow and Rectal Anaerobe Cellular CO2 Production in Patients After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00547859
- Acronym / sponsor ID
- TPO 503
- Conditions
- Cardiac Surgery
- Keywords
- microcirculation, cardiac surgery, metabolism, capnometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 23 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to correlate microcirculatory flow and rectal anaerobe cellular CO2 production in patients after cardiac surgery. The hypothesis is that such a correlation exists.
Detailed description
Sidestream Darkfield imaging is used to determine rectal microcirculatory flow in patients after postoperative cardiac surgery. At the same time PCO2 gap is established by monitoring rectal CO2 (tonometry) and arterial CO2 After initial enrollment and first analysis we also includes a control group with equal inclusion criteria for sublingual SDF imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- post cardiac surgery patients in the first two hours of ICU treatment
Key inclusion criteria (3 listed)
- cardiac surgery
- informed consent
- age > 18
Key exclusion criteria (3 listed)
- pregnancy
- off pump procedure
- rectal fecal contamination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relation between MFI (by SDF) and capno
Time frame: 6 months
1 secondary outcome
Relevance of changes in flow and metabolism
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2008.
- Background: PubMed 16280059Boerma EC, Mathura KR, van der Voort PH, Spronk PE, Ince C. Quantifying bedside-derived imaging of microcirculatory abnormalities in septic patients: a prospective validation study. Crit Care. 2005;9(6):R601-6. doi: 10.1186/cc3809. Epub 2005 Sep 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E.C. Boerma, MD principal investigator
Frisius Medisch Centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, run by Frisius Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation between MFI (by SDF) and capno (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00547859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2008.